FDA Registration Active 🇺🇸 United States

BREG, INC.

Reg #: 3010694026 · FEI: 3010694026 · Expires 2026
Products
33
Proprietary Names
274
Establishment Types
1
Classifications
33

Registration Details

Registration Name
BREG, INC.
Registration Number
3010694026
FEI Number
3010694026
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2835 Fortune Cir W
City
Indianapolis
State
IN
ZIP
46241
Country
US

Regulatory Submissions

510(k) Number
K202839

Owner / Operator

Firm Name
Breg Inc
Operator Number
10041297
Address
2382 Faraday Avenue, Suite 300
City
Carlsbad
State
CA
Postal Code
92008
Country
US
Correspondent
Monique Zamora

Products

Device Name Product Code
Orthosis, Thoracic IPT
Pack, Hot Or Cold, Water Circulating ILO
Cane IPS
Sleeve, Limb, Compressible JOW
Crutch IPR
Bag, Ice KYR
Orthosis, Cervical IQK
Pack, Hot Or Cold, Reusable IME
Orthosis, Lumbo-Sacral IPY
Tape And Bandage, Adhesive KGX
Joint, Hip, External Brace ITS
Shoe, Cast IPG
Orthosis, Limb Brace IQI
Tape, Orthopedic HXT
Binder, Abdominal FSD
Splint, Clavicle IQJ
Splint, Hand, And Components ILH
Sling, Arm ILI
Insoles, Medical KYS
Massager, Powered Inflatable Tube IRP
Support, Arm IOY
Orthosis, Truncal/Orthosis, Limb MRI
Orthosis, Abdominal KTD
Splint, Temporary Training IQM
Cushion, Flotation KIC
Sling, Arm, Overhead Supported ILE
Joint, Ankle, External Brace ITW
Joint, Knee, External Brace ITQ
Walker, Mechanical ITJ
Components, Exercise IOD
Orthosis, Lumbar IQE
Orthosis, Rib Fracture, Soft IPX
Cover, Limb IPM

Proprietary Names

Pro-Fitt TLSO Actimove Loc 462 Ascend TLSO 456/457 Pinnacle TLSO 464 Epic LP TLSO 456 Accessories - Conversion Pad, Extension Panel IntelliFlo Pads Wrap on Polar Pads Glacier, Glacier Combo Kodiak, Kodiak Combo Cube, Cube Combo Accessories - Y-Adapter, Transformer, Strap, Battery Pack, Bed Hanger, Extension Tube Canes DVT Guardian Crutches Polar Care Cub, Cub Combo Breg Ice Bags Polar Pad Cervical Collar Cervical Traction Kit Pinnacle 172/174/180 Ascend Pediatric Collar Ascend Cervical Collar Pinnacle CTO4 Pinnacle CTO Accessories - Back Panel, Front Panel, Pad Kit, Upgrade Kit, Conversion Kit, Pads Carlsbad Cervical Collar Gel Pad Gel Wrap Cryo Pad Universal Polar Wraps Gel Pack Abdominal Binder Cervical Collar Serpentine Clavicle Support Cervical Collar with Open Trachea Intelli-Flo Dressing Polar Dressing T-Scope Hip Simple Pelvic Centron Hip Philippon Accessories - Surgical Kit, Surgical Boot, Peroneal Post, Thigh/Pelvic Pad, Cuff, Strap clip, Y-Tab POST-OP SHOE PED POST-OP SHOE MENS & WOMENS SQ TOE POST-OP SHOE KNOCKOUT WRIST NEUTRAL HAND ATTACHMENT CX2K ESSENTIAL ELBOW IMMOB THIGH SUPPORT STACK FINGER SPLINT TENNIS ELBOW STRAP ADJ DONUT CALF SLEEVE ADJ NIGHT SPLINT PHX HAND EXT TENDON COMPRESSION STRAP UNIVERSAL HORESHOE HINGED KNEE BRACE SOFTGAIT ALIGNER PHX WRIST LACER KNEE SUPPORT ELBOW TSCOPE BUTTRESS SUPPORT LAT STABILIZER X2K ELBOW M-BRACE PATELLA STABILIZER T-CHECK LACE UP ANKLE ARC DYNAMIC Synthocast Maternity Belt ABDUCTION PILLOW CONTOURED FastForm SCB VERSI Strip FastForm SCB Universal Gutter Multifunctional Orthosis FastForm Wrist Cast FastForm SCB Hook & Loop refresh Strips FastForm SCB Short Arm Multifunctional Orthosis FastForm SCB Thumb Spica Multifunctional Orthosis Elasto-Fit Wrist Support Vinyl Splint Thumb Support Wrist Guard Universal Wrist Splint Universal Wrist Brace Classic Wrist Brace Versafit Wrist Brace Versafit Thumb Contender Brace Wrist Stabilizer Cock-Up Thumb Guard Wrist Cock Up Splint Thumbster Low Profile Wrist Premier Thumb Splint Wrist Mate Wrist Lacer Wrist Pro Apollo Wrist Brace Wrist Complete FastForm SCB Immobilizer FastForm SCB Hand-based thumb Spica Orthosis FastForm SCB Tension Straps Universal Thumb Lacer FastForm SCB VERSI Sheet Deluxe Shoulder Sling Arc 2 Essential Shoulder Immob. Essential Shoulder Sling Shoulder Immob. Deluxe Slingshot 3 Shoulder Abduction Pillow Slingshot Neutral Wedge Atlas Shoulder Brace Curtis Shoulder Sleeve Kool Sling Sling and Swathe Universal Curtis Shoulder Cuff Slingshot 2 Straight Shoulder Immobilizer Accessories - Waistband Strap, Shoulder Stabilizer, Sling Pediatric Accessories - Extension Strap, Closure Extension, Shoulder Strap, Hand Attachment, Shoulder Pad, Abduction Pillow PRESSURE RELIEF PAD Silicone Heel Cup Heel Lift Polar Care Wave Cold Compression Pad Transformer Y-Adapter VOLLEY TENNIS ELBOW Universal Arm Elevator Ortholux Ace Centron Lumbolux Ninja Vertalux Extender Surgical Binder Plantar Fascitic Soft Night Splint Bunion Splint Night Splint Viscoelastic Insole Ambulite Elbow VPulse Podus Guard Dorsal Night Splint Heelbo Wee Walker Achilles Boot Ultimate Ankle Axiom Ankle Integrity Walker Mid-Calf Boot AdjustaFit Boot Flatform Boot J Walker Conformer ProGait Bunion Boot Boot Cover Charcot Conformer Plantar Fasciitis Splint Hi Top / Lo Top Performance Knit Ankle Ankle Quick Wrap Wraptor VersaStrap Ankle Ankle Lace up Ankle Elastic Support Multi-Stay Ankle Shell Ankle Walker KoolAir Ankle Controlled ROM Walker Ankle Sprain Kit Boot Acsy Kit Extension Strap Ankle Stirrup Silicone Elastic Ankle Support Mini Walker Vectra Walker Ankle Brace Lock (ABL) Pin Cam Walker Ultra Ankle Ankle Walker Vectra Pro Walker Vectra Wee Walker Achilles Wedge Accessories - Cuff Kit, Bootie, Pads, Air Bladder, Straps Tri-Panel Knee Immob Original Knee OR Merit Z-13 Axiom Wee-Rom Z-12 20.50 Patellofemoral DUO Jet Thruster RLF Revolution 3 G3 Extender Plus Quantum OA T-Scope Premier Post-Op LPR Latitude OA Knee Genesis Undersleeve Patella Guard Hi-Performance Hinged Knee FreeRunner Lateral Stabilizer EPO Recover X2K Knee Brace OA Impulse Economy Hinged Knee Slide Guard ShortRunner PTO Crossover Hinge Cover RoadRunner Freestyle FreeSport Solus Knee Brace Fusion Knee Accessories - Condyle and Hook, Patella Buttress, Strap set, Strap Tab, Strap Pad, Calf Strap, Condyle, Hex Key MC Knee Brace Knee Support Accessories - Stop Kit, Soft Toe Guard, Soft Goods, Shoe Insert, Buckle, Chafe Tab, Shoe insert, Hard toe guard Accessories - Incision Pad, Pad, Pad Kit, Refurb Kit, Cuff, Wrap Set, Hinge Kit, Shims Kit CrossRunner Performance Knit Hinged Measuring System, Fit Kit Freestyle Plus TopShelf Fusion Strap Set Single Panel Knee Immob Walkers Ankle Therapy Kit Knee Therapy Kit Shoulder Therapy Kit System Loc Actimove Fit 627 Actimove Fit 631 Actimove Fit 637 V-Loc Cinch Loc Lumbar Loc Pro-Fitt LSO Core Loc Deluxe Pinnacle 627/631/637/639 Ascend SI Ascend 627/631/637 Epic LP LO627/LSO631/LSO637 Lumbar Support Back Support BOA Back Brace Accessories - Extension Panel, Pad Kit, Upgrade Kit, Back Pad Essential Spine 627/642, 631/648, 637/650 Pinnacle Belt/LSO Ascend LSO Rib Belt Elbow/Knee Sleeve Brace Cover Suspension Sleeve

Establishment Types

Repack or Relabel Medical Device